Department of Dermatology, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
NCT Number: NCT01773694
Patients are often counseled to keep a surgical wound dry for 2 to 3 days. The rationale is likely to decrease the risk of infection and bleeding. However, this has never been formally studied. Patient's routines are likely disrupted when they are asked to avoid wetting the area. The investigators will perform a controlled study to determine if avoidance of post-operative wetting is necessary.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hershey, Pennsylvania, 17033, United States
Physicians commonly instruct their patients to keep a wound dry for 2 to 3 days following surgery. The rationale may be that sources of water like a shower, bathtub, or swimming pool may increase the risk of infection. There may also be a concern that changing a dressing in the early post-operative period will increase the risk of bleeding complications. However, patient's routines and quality of life are disrupted when they are asked to avoid bathing, exercise, and swimming.
These issues have never been formally studied. This study will test the hypothesis of whether early post-operative wetting will have any influence on infection rates, bleeding complications, or the appearance of a surgical wound. Patients presenting to the Penn State Hershey dermatology clinic for the surgical removal of cancerous or non-cancerous skin lesions will be invited to participate. There will be no change to the standard surgical treatment. The dressing will be the same for all study participants. After surgery, study subjects who consent to participate will be randomized to receive one of two sets of post-operative instructions. One group will be directed to keep their initial post-operative dressing intact and dry for 48 hours. The second group will remove the dressing at 6 hours and wet the wound for 10 minutes in whatever manner they choose (shower, bath, pool, hot tub, etc.). After the initial dressing is removed (at 48 hours or 6 hours), both groups will perform identical post-operative care, consisting of cleansing the wound with soap and water followed by the application of petrolatum ointment and a dry dressing.
All participants will follow-up 7 to 14 days after surgery or earlier if they are experiencing any problems. At this time, the site will be assessed for clinical evidence of infection and bleeding. If the former is present, a bacterial culture will be obtained to confirm a wound infection and patients will be treated with an antibiotic. Physicians performing the assessment will be blinded to the patient's status (early wetting group or not). All subjects will also complete a questionnaire inquiring how and when they wet their wounds after surgery as well as two questionnaires asking how their quality-of-life and function were affected. Participants will again follow-up at 6 months when a blinded investigator will assess the cosmetic appearance of the scars using an established scar rating tool.
The data from this study will provide valuable evidence based guidance to surgeons in drafting wound care instructions for their patients. If the hypothesis proves correct, patients may be spared the inconvenience of post-operative water avoidance, diminishing the disruption to their lives caused by skin surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Early Water Exposure (Intervention) group will receive written and verbal instructions to remove the dressing after 6 hours and wet the wound for at least 10 minutes. Wetting of the wound will include shower, tub bath, or pool exposure.
On subsequent days, all participants, regardless of group assignment, will wash the wound daily with soap and water, reapply white petrolatum and a dry dressing.
Time frame: Post-operative day 7 to 14
Time frame: Post-operative day 7 to 14
Time frame: 6 months post-operatively (+-5 days)
Using a non-invasive scoring tool, participants and a blinded physician will rate the appearance of the scar 6 months after the surgery.
Time frame: Post-operative days 7 to14
Using a validated survey, information on the participants' quality of life will be assessed.
Milton S. Hershey Medical Center
Other
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